Retrospective economic evaluation of a controlled trial of indomethacin prophylaxis for patent ductus arteriosus in premature infants.

OBJECTIVE: To determine the incremental cost-effectiveness of indomethacin prophylaxis in extremely low birth weight infants enrolled in the Trial of Indomethacin Prophylaxis in Preterms (TIPP). STUDY DESIGN: Participants in this economic evaluation were 428 infants enrolled at 9 Canadian TIPP centres. The study took a third-party payer perspective. Prior to the analysis of clinical trial data, direct medical costs were derived from chart review of 89 items of resource utilization, for each day from admission to hospital discharge. Unit costs for each resource were obtained from a provincially standardized cost-accounting system. Incremental cost-effectiveness analysis was performed, with estimation of cost-effectiveness acceptability curves through non-parametric bootstrapping. RESULTS: The mean (SD) cost was $68,279 (40,317) for the placebo group and $69,629 (37,989) for the indomethacin group. Indomethacin prophylaxis cost an additional $67,500 per death or impairment averted. However, the precision of this estimate was low, such that the probability that the estimate was lower than $300,000 per death or impairment averted was only 61%. The results were similar when surgical costs were assumed to be 500% of those measured in the trial. CONCLUSIONS: This study does not provide an economic rationale for the use of indomethacin prophylaxis in ELBW infants.